Paragraph 33 Variation of a marketing authorisation

England, Wales and Scotland

F1(1)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2)

The holder of a marketing authorisation may apply to the Secretary of State for a variation of that marketing authorisation.

F2(3)

An application for a variation under paragraph (2) may only relate to—

(a)

a single variation, which may relate to one or more marketing authorisations, or

(b)

one or more variations to a single marketing authorisation.

(4)

The Secretary of State, when granting a variation of a veterinary medicinal product, may (unless there are exceptional circumstances necessary to protect human or animal health or the environment) specify transitional measures to enable products produced in accordance with the previous authorisation to continue to be marketed for the transitional period.

Annotations

Textual amendments

F1: Sch. 1 para. 33(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 53(a)
F2: Sch. 1 para. 33(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 53(b)

Notes on Schedule 1

Textual amendments

F1: Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)
F2: Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)